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Upright MRI for Prostate Cancer Screening

NCT03474913 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 550

Last updated 2026-01-07

No results posted yet for this study

Summary

This is an investigator initiated study to test the efficacy of an upright MRI (Magnetic Resonance Imaging) for the screening of prostate cancer. The purpose of this study is to compare Upright MRI as a technique to PSA (Prostate Specific Antigen) and current MRI imaging. It will take place at Mount Sinai Hospital, and last for a total of about 5 years. Eligible patients will be determined by the urologist. The target population is men who are at risk for prostate cancer, as determined by the urologist. Diagnostic criteria will include elevated PSA and an abnormal digital rectal exam (DRE). After patients are screened and determined eligible, they will be asked to have a seated MRI using the Indomitable Magnetic Resonance Imaging Scanner, Ex vivo magnetic resonance imaging using 0.6 T strength, as well as a standard of care closed 3T MRI. After each scan, the patient will be given a series of questionnaires to assess their comfort level during the scan. Patients will be followed every 6 months after completion of (or early withdrawal from) study enrollment until 5 years.

Conditions

Interventions

DEVICE

Upright MRI

Indomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength

DEVICE

Standard MRI

standard of care closed 3T MRI

Sponsors & Collaborators

Principal Investigators

  • Ash Tewari, MD · Icahn School of Medicine at Mount Sinai

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2026-07-01
Completion
2026-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03474913 on ClinicalTrials.gov